everlinQ Endovascular Access Systems Enhancements (EASE-2) Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Chronic Kidney Diseases
- Sponsor
- C. R. Bard
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Number of Participants With Procedural Success
- Status
- Completed
- Last Updated
- 4 months ago
Overview
Brief Summary
Prospective, single-center study to evaluate the everlinQ endoAVF System when used to create an endoAVF in hemodialysis patients. This study aims to investigate expansion of the percutaneous venous access location to the superficial system which may provide additional procedural benefit.
Detailed Description
A total of up to 50 subjects will be enrolled and will undergo an endoAVF creation procedure using the everlinQ System. All subjects may be followed for up to 12 months post index procedure based on Investigator's discretion. The duration of the study is expected to be approximately two (2) years.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Eligible for a native arteriovenous fistula.
- •Adult (age \>18 years old).
- •Established, non-reversible kidney failure requiring hemodialysis (including pre-dialysis patients).
- •Target vein diameter(s) at fistula site ≥ 2.0 mm.
- •Target artery diameter at fistula site ≥ 2.0 mm.
- •Procedural access site artery and vein diameter ≥ 2.0 mm.
- •At least one superficial outflow vein diameter ≥ 2.5 mm and in communication with the perforating vein.
- •Estimated life expectancy \> 1 year.
- •Patient is free of clinically significant conditions or illness within 30 days prior to the AV fistula that may compromise the procedure.
- •Presence of an antecubital perforating vein diameter ≥ 2.0 mm.
Exclusion Criteria
- •Known central venous stenosis or central vein narrowing \> 50% based on imaging on the same side as the planned AVF creation.
- •Upper extremity venous occlusion(s) and/or vessel abnormality(ies) on the same side as the planned AVF creation that precludes endovascular AVF creation by the everlinQ System as deemed by the interventionalists' clinical judgment.
- •Prior surgically created access in the planned treatment location.
- •Functioning surgical access in the planned treatment arm.
- •Pregnant women.
- •New York Heart Association (NYHA) class III or IV heart failure.
- •Hypercoagulable state.
- •Known bleeding diathesis.
- •Immunosuppression, defined as use of immunosuppressive medications used to treat an active condition.
- •Documented history of drug abuse including intravenous drugs within six months of AVF creation.
Outcomes
Primary Outcomes
Number of Participants With Procedural Success
Time Frame: At time of procedure
Procedure Success was defined as successful endoAVF creation confirmed via intraprocedural angiography/fistulogram or duplex ultrasound verification performed post procedure.
Adverse Event Rate
Time Frame: 3 months following endoAVF creation
Percentage of patients who experience one or more adverse events during the first 3 months following successful endoAVF creation. Adverse events were site-reported and reviewed by an independent Medical Monitor and the Clinical Events Committee (CEC).
Secondary Outcomes
- Number of Participants With Cannulation Success at Defined Follow-up Intervals(0-10 days, 11-45 days, 46-135 days, 136-210 days post index procedure)
- Percentage of Participants With Assisted Primary Patency at 6 Months(6 months post index procedure)
- Number of Participants With EndoAVF Related Reintervention(At 6 months follow-up)
- Percentage of Participants With Modified Primary Patency at 6 Months Post Index Procedure(6 months post index procedure)
- Percentage of Participants With Primary Patency at 6 Months Post Index Procedure(6 months post index procedure)
- Time to Cannulation (Months)(Months from index procedure to cannulation)
- Number of Participants With EndoAVF Maturation at 1, 3, and 6 Months Post Index Procedure(1, 3, and 6 months post index procedure)
- Percentage of Participants With Secondary Patency at 6 Months Post Index Procedure(6 months post index procedure)
- Percentage of Participants With Functional Patency of the endoAVF at 6 Months Post Index Procedure(6 months post index procedure)